Letters: 'Biosimilars' and patient safety

I would like to point out several patient safety concerns with "biosimilars," cheaper versions of biologic drugs that are derived from living cells.

Although the U.S. Food and Drug Administration's safety adjudications are important, the FDA has been wrong before. Recent withdrawal of one form of the antidepressant bupropion and safety warnings for virtually all blockbuster drugs have occurred. Such mistakes can be more harmful in biosimilars. They are not small-mol- ecule pills; they are complex medicines that work at fundamental levels of the cell. Allergic reactions are life-threatening.

Finally, the naming of biosimilars globally has not been agreed upon, so it's important for physicians to be notified when a patient's biologic prescription has been substituted with a biosimilar. California's

SB 598 allows this substitution but recognizes the importance of ensuring a patient's physician is informed when a biosimilar medicine is substituted. It's a common-sense patient safety safeguard.

Bryan A. Liang, MD

San Diego

The writer, an anesthesiologist and lawyer, directs the San Diego Center for Patient Safety and is a professor of health law at California Western School of Law.